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    Summary
    EudraCT Number:2005-000949-11
    Sponsor's Protocol Code Number:0683-014
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-01-25
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2005-000949-11
    A.3Full title of the trial
    “Estudio fase III, aleatorizado, doble ciego, controlado con placebo, de ácido hidroxámico suberoilanilida oral (Vorinostat, MK 0683), en pacientes con mesotelioma pleural maligno avanzado, tratado previamente con quimioterapia sistémica.”
    A.4.1Sponsor's protocol code number0683-014
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Sharp and Dohme de España
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameácido hidroxámico suberoilanilida (SAHA)
    D.3.2Product code CN-0683/L-001079038
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 149647-78-9
    D.3.9.2Current sponsor codeCN-0683/L-00107938
    D.3.9.3Other descriptive nameN hidroxi Nfenil octan o 1,8
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typemedicación oncológica citotóxica
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Mesotelioma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLGT
    E.1.2Classification code 10027412
    E.1.2Term Mesotheliomas
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10027406
    E.1.2Term Mesothelioma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparar la supervivencia global asociada a vorinostat más la mejor asistencia de apoyo con la supervivencia asociada a placebo más la mejor asistencia de apoyo para el tratamiento de los pacientes con mesotelioma pleural maligno avanzado que no han respondido al menos a una pauta de quimioterapia previa, y determinar la seguridad global y la toxicidad de vorinostat en esta población
    E.2.2Secondary objectives of the trial
    Comparar vorinostat más la mejor asistencia de apoyo con placebo más la mejor asistencia de apoyo para el tratamiento de los pacientes con mesotelioma pleural maligno avanzado que no han respondido al menos a una pauta de quimioterapia previa con respecto a:
    a.Supervivencia sin progresión
    b.Tasa de respuesta objetiva global
    c.Puntuación de la disnea en la escala de síntomas del cáncer pulmonar modificada para el mesotelioma (LCSS Meso) en la semana 12; y
    d.Cambio porcentual con respecto al valor basal en la capacidad vital forzada (FVC) en la semana 12.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient must have a histologically and/or cytologically confirmed diagnosis of epithelial, sarcomatoid, or mixed histology malignant pleural mesothelioma, which has progressed or relapsed following standard treatment which included pemetrexed in combination with either cisplatin or carboplatin. The most recent regimen must have contained pemetrexed Patient has had no more than one previous systemic therapy regimen other than pemetrexed in combination with cisplatin or carboplatin; the most recent regimen must have contained pemetrexed Patient must have at least 1 lesion that can be measured by using the modified RECIST [10], i.e., is at least 1.5 cm in diameter on a spiral computerized tomography (CT) scan.
    E.4Principal exclusion criteria
    Pacientes que hayan recibido tratamiento previo con un inhibidor de la HDAC (p. ej., depsipéptido, MS 275, LAQ 824, PXD 101 y ácido valproico). Los pacientes que hayan recibido dichos fármacos para otras indicaciones, por ejemplo, epilepsia, podrán participar en ensayos de vorinostat tras un período de lavado de 30 días.Pacientes con infección activa para la que hayan recibido antibióticos, antivirales o antifúngicos por vía intravenosa en las dos semanas anteriores al comienzo del fármaco del estudio.Los pacientes con una segunda neoplasia maligna “actualmente activa" distinta de cáncer de piel que no sea melanoma y del carcinoma de cuello uterino in situ serán excluidos. Se considerará que el paciente no tiene una segunda neoplasia maligna "actualmente activa” si ha completado el tratamiento para el segundo tumor maligno y no ha presentado la enfermedad maligna previa en los últimos > 5 años.Pacientes con metástasis cerebrales no controladas, por ejemplo, metástasis cerebrales tratadas previamente que no se hayan estabilizado en las últimas 6 semanas.
    E.5 End points
    E.5.1Primary end point(s)
    La variable de eficacia principal será la supervivencia.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA39
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    El primer análisis intermedio se realizará cuando 50 pacientes hayan alcanzado el seguimiento a las 18
    semanas. El segundo análisis intermedio se llevará a cabo cuando se hayan producido unas 135
    muertes. El tercer análisis intermedio se llevará acabo cuando se hayan producido unos 270
    fallecimientos.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 357
    F.4.2.2In the whole clinical trial 660
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2005-08-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-06-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-11-21
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